This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates.
This document is applicable to:
— concentrates in both liquid and powder forms;
— additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid;
— equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
This document does not apply to:
— concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility;
— pre-packaged and sterile dialysis fluid;
— sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid;
— equipment to perform patient treatment; this is addressed IEC 60601-2-16.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
